GUEST COLUMNISTS

• From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations

  The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.

• The Systems And Choreography Needed For Grade B ATMP Material Transfer

  Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.

• Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign

  The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

• Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity

  Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.

• Navigating GMP Biosafety Challenges In ATMP Manufacturing

  BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance.

• Generative AI Can Write The Code, But Who Builds In The Quality?

  Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

• UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk

  Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

• February 2026 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.